Stephen Goodwin. VP, Operations 1 Oct 2015 LabKey User Conference & Workshop 2015

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1 HJF s Journey Stephen Goodwin VP, Operations 1 Oct 2015 LabKey User Conference & Workshop 2015

2 About HJF Private, not-for-profit organization Authorized by Congress in 1983 We serve military medicine and Uniformed Services University of the Health Sciences

3 Our Mission Advancing military medical research

4 A Brief History In 1983, President Reagan signed congressional legislation establishing HJF Sen. Henry M. Scoop Jackson championed the bill in Congress Company renamed in his honor shortly after his death

5 Our Where Presence We Work Nearly 2,450 employees 100 locations worldwide 28 states and D.C. 10 foreign nations Nearly 90 percent work on research and clinical studies

6 U.S. Military HIV Research Program In 1985, Congress directed DoD to study HIV disease and its impact on military readiness through the U.S. Military HIV Research Program Focus: Develop a globally effective HIV-1 vaccine and provide prevention, care and treatment

7 HIV and the Military An effective HIV vaccine is needed to: End the pandemic Protect deployed U.S. and allied troops Stabilize key partners affected by AIDS

8 MHRP s Global Research Effort Robust international research infrastructure and clinical trial capabilities Unique combination of research and care in endemic settings WRAIR/MHRP Maryland MUWRP-Uganda WRP Kenya DoDHP-Nigeria WRP-Tanzania Mozambique USAMC-AFRIMS Bangkok, Thailand U.S. President s Emergency Plan for AIDS Relief (PEPFAR)

9 HJF (MHRP) and LabKey Beginnings Our journey started (a long time ago) with an article about Neutralizing Antibody (NAb) assays and LabKey MHRP s Dr. Shelly Krebs saw that LabKey had automated analysis for others using similar NAb assays Software like LabKey was new to MHRP researchers with some assembly required

10 Improved NAb Assay Tool Shelly s team works with LabKey to demonstrate capabilities for the NAb assay using LabKey hosted environment LabKey Services customizes the NAb assay to provide: 384-well plate layout 2 viruses per plate

11 Improved NAb Assay Tool continued New import formats New export utility

12 The (boundaries of) Automation Challenge LabKey s modification offers huge efficiency gains for the lab s NAb assay Almost immediately Shelly s lab looks at additional automation Many different levels of need and opportunity exist for different laboratory groups as regards laboratory workflows

13 The LabKey Word Spreads LabKey evangelism takes hold within MHRP s labs Other labs express both interest and doubts but agree that the product offers promise for streamlining some assays and related analyses Then others within MHRP, but outside of the laboratory space take an interest

14 LabKey as an Integration Platform The concept and value of using LabKey to provide an integrated view of Program studies takes hold Soon we are prototyping our first MHRP protocol within LabKey as we learn the mechanics of LabKey studies

15 MHRP Studies are Primarily Overseas Operations in multiple countries and often multiple locations within countries Building infrastructure and research capacity in country is part of the mission Challenges among them are Information and Communications Technology (ICT)

16 Evolution of Program Data Communications Initially very limited Later limited terrestrial and then satellite based Now improved terrestrial but still episodic issues Cellular technologies widespread and increased pressure for distributed operations isolated systems with periodic data transfers interactive applications can suffer from reliability issues off-line computing with uplink mobile devices for EDC

17 MHRP (internal) LabKey Portal - WARP Next uses within MHRP: studies supporting information site specimens site clinical data site laboratory data related research data reporting sharing

18 LIMS Secure Web Front End Another LabKey use within MHRP now in development HIV diagnostic group running LabWare LIMS LabKey Services building a secure web front end to LabWare LIMS to allow customers to: request tests retrieve results

19 LIMS Secure Web Front End continued Application design emphasis on security and audit for intrinsically sensitive data Simple UI to submit test requests and to provide specimen shipping information but not such a simple workflow

20 LIMS Secure Web Front End continued LabKey Services designed integration to support Two- Factor Authentication (2FA) Using Duo Security at present Important improvement in application security, but not without its own challenges

21 MHRP LabKey Summary Laboratory workflows within the domestic lab space Integrated overview of disparate program data Uses in overseas sites, communications permitting Learning and adoption curves, standardization, coordination and staffing External collaborators

22 ACESO (Austere environments Consortium for Enhanced Sepsis Outcomes)

23 ACESO (Austere environments Consortium for Enhanced Sepsis Outcomes) SEPSIS Aceso (Ἀκεσώ) Greek goddess of healing wounds and curing illness

24 Severe Sepsis Bloodstream infection by any pathogen (bacterial, viral, fungal, parasitic, etc.) leading to: an overwhelming inflammatory response septic shock with damage to vital organs A leading cause of mortality in both developed and developing countries Supportive care, ICUs in developed countries Involved in >10% military multi-trauma patients

25 Aims Our Presence of ACESO Improve adult patient survival in austere settings through: early recognition of disease identifying useful biomarker panels evidence-based clinical management

26 The ACESO Network The collaborative research effort includes the NMRC, LLNL, American and Ugandan universities, and U.S. Navy medical laboratories in Egypt Cambodia, and West Africa Lawrence Livermore National Laboratory Naval Medical Research Center Frederick, MD U.S. Universities: Naval Medical Duke, George Research Unit Mason and Naval Medical Egypt University of Research Unit Washington Ghana Detachment Uganda Makerere University Walter Reed Project Naval Medical Research Unit Cambodia

27 ACESO and LabKey Initial phase: aggregate clinical and laboratory data from Program sites Follow on: automate lab workflows automate QC processes reporting

28 ACESO Futures More than Sepsis Future challenges: more remote locations more austere conditions disconnected data collection mobile medical teams

29 Research Data Trends clinical data paper CRFs electronic CRFs mobile electronic CRFs raw data wearables laboratory data volume complexity analytics collaboration

30 HJF and LabKey Summary flexible standard framework open source model and technologies community and professional services complements existing applications collaboration/communication line-of-business for research labs

31 Acknowledgments LabKey Software Josh Eckels, Britt Piehler, Karl Lum, others MHRP Dr. Shelly Krebs, Dr. Leigh Anne Eller and many others ACESO Janice Hepburn, others HJF IT Services Chris Schoening, Nickhat Zafar, IT Operations team US Government Sponsors and Collaborators

32 Questions & Discussion

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